Illinois General Assembly - Full Text of HB0119
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Full Text of HB0119  102nd General Assembly

HB0119enr 102ND GENERAL ASSEMBLY



 


 
HB0119 EnrolledLRB102 04093 CPF 14109 b

1    AN ACT concerning health.
 
2    Be it enacted by the People of the State of Illinois,
3represented in the General Assembly:
 
4    Section 1. Short title. This Act may be cited as the
5Illinois Drug Reuse Opportunity Program Act.
 
6    Section 5. Definitions. In this Act:
7    "Controlled substance" means a drug, substance, or
8immediate precursor in Schedules I through V of 21 CFR 1308.
9    "Dispense" has the same meaning as defined in Section 3 of
10the Pharmacy Practice Act.
11    "Donor" means any person, including an individual member
12of the public, or any entity legally authorized to possess
13medicine, including, but not limited to, a wholesaler or
14distributor, third party logistic provider, pharmacy,
15dispenser, clinic, surgical or health center, detention and
16rehabilitation center, jail, prison laboratory, medical or
17pharmacy school, prescriber or other health care professional,
18long-term care facility, or healthcare facility. "Donor"
19includes government agencies and entities that are federally
20authorized to possess medicine, including, but not limited to,
21drug manufacturers, repackagers, relabelers, outsourcing
22facilities, health care facilities operated by the U.S.
23Department of Veterans Affairs, and prisons.

 

 

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1    "Drug" means a prescription drug, over-the-counter drug,
2or supplies needed to administer a prescription or
3over-the-counter drug.
4    "Eligible patient" means an individual:
5        (1) with a prescription for the drug, if a
6    prescription is required to dispense the drug, or who
7    reports symptoms treated by the drug if the drug is
8    over-the-counter; and
9        (2) who is registered with the drug's manufacturer in
10    accordance with federal Food and Drug Administration
11    requirements, if the registration is required to dispense
12    the drug.
13    "Manufacturer" has the same meaning as defined in Section
1415 of the Wholesale Drug Distribution Licensing Act.
15    "Pharmacist" means an individual licensed to engage in the
16practice of pharmacy under the Pharmacy Practice Act or
17licensed to engage in the practice of pharmacy in another
18state.
19    "Practitioner" means a person licensed in this State to
20dispense or administer drugs or who is licensed in another
21state as a person authorized to dispense or administer drugs.
22    "Prescription drug" means any prescribed drug that may be
23legally dispensed by a pharmacy. "Prescription drug" does not
24include a drug for the treatment of cancer that can only be
25dispensed to a patient registered with the drug manufacturer
26in accordance with the federal Food and Drug Administration's

 

 

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1requirements.
2    "Priority patient" means an eligible patient who is an
3Illinois resident and who is indigent, uninsured,
4underinsured, or enrolled in a public health benefits program.
5    "Recipient" means any person or entity legally authorized
6to possess medicine with a license or permit in the state in
7which the person or entity is located, including, but not
8limited to, a wholesaler or distributor, reverse distributor,
9repackager, hospital, pharmacy, or clinic.
10    "Returns processor" has the same meaning as defined in
11paragraph (18) of 21 U.S.C. 360eee. "Returns processor"
12includes, but is not limited to, a reverse distributor.
13    "Unopened tamper-evident packaging" has the same meaning
14as defined in the United States Pharmacopeia (USP) General
15Chapter 659, Packaging and Storage Requirements, including,
16but not limited to, unopened unit-dose, multiple-dose,
17immediate, secondary, and tertiary packaging.
 
18    Section 10. Donating and receiving drugs. Notwithstanding
19any other law or rule, donors may donate drugs to recipients
20and recipients may receive donated drugs from donors.
21Recipients shall only dispense or administer drugs to eligible
22patients as described in Section 20, further donate drugs to
23another recipient as described in Section 30, or dispose of
24drugs as described in Section 35.
 

 

 

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1    Section 15. Cost-free provision of drugs. Drugs donated
2for use under this Act are considered nonsaleable. When
3dispensing a drug to an eligible patient, the recipient must
4do so at no cost to the eligible patient, except that a uniform
5reasonable handling fee may be charged. The handling fee may
6not exceed the direct or indirect cost to the recipient of
7providing the drug. Charging the fee does not constitute
8reselling.
 
9    Section 20. Requirements for dispensing drugs; priority.
10    (a) A recipient may only dispense or administer a
11prescription drug or provide an over-the-counter drug:
12        (1) if the recipient is otherwise permitted by law to
13    dispense or administer the drug;
14        (2) that meets the requirements in Section 25;
15        (3) that is repackaged into a new container or is in
16    its original container with all previous patient
17    information redacted or removed;
18        (4) that is properly labeled in accordance with the
19    rules and regulations of the Board of Pharmacy;
20        (5) that has an expiration or beyond-use date brought
21    forward from the donated prescription drug or
22    over-the-counter drug that will not expire before the use
23    by the eligible patient based on the prescribing
24    practitioner's directions for use or, for over-the-counter
25    medicine, on the package's label; and

 

 

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1        (6) that is not adulterated or misbranded, as
2    determined by a pharmacist or practitioner.
3    (b) Recipients shall, to the greatest extent practicable,
4dispense drugs received under this Act to priority patients.
 
5    Section 25. Requirements for accepting drugs. A drug
6received but not yet accepted into inventory shall be kept in a
7separate designated area. A drug may be accepted under this
8Act only if all of the following requirements are met:
9        (1) The drug is in unopened tamper-evident packaging
10    or has been repackaged according to Section 30.
11        (2) The drug is not expired.
12        (3) The drug is not a controlled substance.
13        (4) The recipient maintains a written or electronic
14    record of a donation made under this Act consisting of the
15    name, strength, and quantity of each accepted drug and the
16    name, address, and telephone number of the donor, unless a
17    recipient is further donating to a recipient under common
18    ownership or common control. Notwithstanding any other law
19    or rule, no other record of a donation is required.
20        (5) The donor has removed or redacted any patient name
21    and prescription number and any other patient identifying
22    information on the drug or otherwise maintains patient
23    confidentiality by executing a confidentiality agreement
24    with the recipient according to all State and federal
25    medical patient privacy laws, rules, or regulations.

 

 

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1        (6) The drug has a method recognized by the United
2    States Pharmacopeia to detect improper temperature
3    variations if the drug requires temperature control other
4    than room temperature storage.
 
5    Section 30. Donating and repackaging. Notwithstanding any
6other law or rule, a recipient may:
7        (1) further donate drugs to another recipient;
8        (2) repackage donated drugs as necessary for storage,
9    dispensing, administration, or transfers in accordance
10    with the following:
11            (A) repackaged medicine shall be labeled with the
12        drug's name, strength, and expiration date, and shall
13        be kept in a separate designated area until inspected
14        and initialed by a pharmacist, practitioner, or a
15        pharmacy technician; and
16            (B) if multiple packaged donated medicines with
17        varied expiration dates are repackaged together, the
18        shortest expiration date shall be used; and
19        (3) replenish a drug of the same drug name and
20    strength previously dispensed or administered to an
21    eligible patient in accordance with Section 340B of the
22    federal Public Health Service Act.
 
23    Section 35. Disposition of drugs. A donated drug that does
24not meet the requirements of Section 25 must be disposed of by

 

 

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1returning it to the donor, destroying it by an incinerator,
2medical waste hauler, or other lawful method, or transferring
3it to a returns processor. A record of disposal shall consist
4of the disposal method, the date of disposal, and the name and
5quantity of the drug disposed of. Notwithstanding any other
6law or rule, no other record of disposal shall be required.
 
7    Section 40. Participation not required. Nothing in this
8Act requires that a pharmacy or pharmacist be a recipient of
9drugs under this Act.
 
10    Section 45. Recordkeeping requirements. When performing
11any action associated with a program under this Act or
12otherwise processing a donated drug for tax, manufacturer, or
13other credit, a recipient shall be considered to be acting as a
14returns processor and shall comply with all recordkeeping
15requirements for nonsaleable returns under federal law.
 
16    Section 50. Change of ownership. A donation or other
17transfer of possession or control of a drug under this Act
18shall not be construed as a change of ownership unless it is
19specified as such by the recipient. If a record of the
20donation's transaction information or history is required, the
21history shall begin with the donor of the drug, include all
22prior donations, and, if the drug was previously dispensed,
23only include drug information required to be on the patient

 

 

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1label in accordance with the Board of Pharmacy's rules and
2regulations.
 
3    Section 55. Retention of records. All records required
4under this Act shall be retained in physical or electronic
5format and on or off the recipient's premises for a period of 6
6years. Donors or recipients may contract with one another or a
7third party to create or maintain records on each other's
8behalf. An identifier, such as a serial number or bar code, may
9be used in place of any or all information required by a record
10or label pursuant to this Act if it allows for such information
11to be readily retrievable. Upon request by a State or federal
12regulatory agency, the identifier used for requested records
13shall be replaced with the original information. An identifier
14shall not be used on patient labels when dispensing or
15administering a drug.
 
16    Section 60. Authority. This Act supersedes any
17inconsistent law or rule for activities conducted under this
18Act.
 
19    Section 65. Immunity.
20    (a) Except as provided in subsection (b), no manufacturer,
21donor, or recipient shall be liable in any criminal or civil
22action, or be subject to professional discipline, for
23activities solely and directly attributable to donating,

 

 

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1receiving, or dispensing drugs under this Act.
2    (b) The immunity provided in subsection (a) shall not
3apply:
4        (1) if it is shown that the act or omission was an
5    unreasonable, willful, wanton, or reckless act;
6        (2) if it is shown that the person or entity knew or
7    should have known that the donated drug was adulterated or
8    misbranded; or
9        (3) to acts or omissions outside the scope of a
10    program under this Act.
 
11    Section 90. The Pharmacy Practice Act is amended by
12changing Section 4 as follows:
 
13    (225 ILCS 85/4)  (from Ch. 111, par. 4124)
14    (Section scheduled to be repealed on January 1, 2023)
15    Sec. 4. Exemptions. Nothing contained in any Section of
16this Act shall apply to, or in any manner interfere with:
17        (a) the lawful practice of any physician licensed to
18    practice medicine in all of its branches, dentist,
19    podiatric physician, veterinarian, or therapeutically or
20    diagnostically certified optometrist within the limits of
21    his or her license, or prevent him or her from supplying to
22    his or her bona fide patients such drugs, medicines, or
23    poisons as may seem to him appropriate;
24        (b) the sale of compressed gases;

 

 

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1        (c) the sale of patent or proprietary medicines and
2    household remedies when sold in original and unbroken
3    packages only, if such patent or proprietary medicines and
4    household remedies be properly and adequately labeled as
5    to content and usage and generally considered and accepted
6    as harmless and nonpoisonous when used according to the
7    directions on the label, and also do not contain opium or
8    coca leaves, or any compound, salt or derivative thereof,
9    or any drug which, according to the latest editions of the
10    following authoritative pharmaceutical treatises and
11    standards, namely, The United States
12    Pharmacopoeia/National Formulary (USP/NF), the United
13    States Dispensatory, and the Accepted Dental Remedies of
14    the Council of Dental Therapeutics of the American Dental
15    Association or any or either of them, in use on the
16    effective date of this Act, or according to the existing
17    provisions of the Federal Food, Drug, and Cosmetic Act and
18    Regulations of the Department of Health and Human
19    Services, Food and Drug Administration, promulgated
20    thereunder now in effect, is designated, described or
21    considered as a narcotic, hypnotic, habit forming,
22    dangerous, or poisonous drug;
23        (d) the sale of poultry and livestock remedies in
24    original and unbroken packages only, labeled for poultry
25    and livestock medication;
26        (e) the sale of poisonous substances or mixture of

 

 

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1    poisonous substances, in unbroken packages, for
2    nonmedicinal use in the arts or industries or for
3    insecticide purposes; provided, they are properly and
4    adequately labeled as to content and such nonmedicinal
5    usage, in conformity with the provisions of all applicable
6    federal, state and local laws and regulations promulgated
7    thereunder now in effect relating thereto and governing
8    the same, and those which are required under such
9    applicable laws and regulations to be labeled with the
10    word "Poison", are also labeled with the word "Poison"
11    printed thereon in prominent type and the name of a
12    readily obtainable antidote with directions for its
13    administration;
14        (f) the delegation of limited prescriptive authority
15    by a physician licensed to practice medicine in all its
16    branches to a physician assistant under Section 7.5 of the
17    Physician Assistant Practice Act of 1987. This delegated
18    authority under Section 7.5 of the Physician Assistant
19    Practice Act of 1987 may, but is not required to, include
20    prescription of controlled substances, as defined in
21    Article II of the Illinois Controlled Substances Act, in
22    accordance with a written supervision agreement;
23        (g) the delegation of prescriptive authority by a
24    physician licensed to practice medicine in all its
25    branches or a licensed podiatric physician to an advanced
26    practice registered nurse in accordance with a written

 

 

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1    collaborative agreement under Sections 65-35 and 65-40 of
2    the Nurse Practice Act; and
3        (g-5) the donation or acceptance, or the packaging,
4    repackaging, or labeling, of drugs to the extent permitted
5    under the Illinois Drug Reuse Opportunity Program Act; and
6        (h) the sale or distribution of dialysate or devices
7    necessary to perform home peritoneal renal dialysis for
8    patients with end-stage renal disease, provided that all
9    of the following conditions are met:
10            (1) the dialysate, comprised of dextrose or
11        icodextrin, or devices are approved or cleared by the
12        federal Food and Drug Administration, as required by
13        federal law;
14            (2) the dialysate or devices are lawfully held by
15        a manufacturer or the manufacturer's agent, which is
16        properly registered with the Board as a manufacturer,
17        third-party logistics provider, or wholesaler;
18            (3) the dialysate or devices are held and
19        delivered to the manufacturer or the manufacturer's
20        agent in the original, sealed packaging from the
21        manufacturing facility;
22            (4) the dialysate or devices are delivered only
23        upon receipt of a physician's prescription by a
24        licensed pharmacy in which the prescription is
25        processed in accordance with provisions set forth in
26        this Act, and the transmittal of an order from the

 

 

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1        licensed pharmacy to the manufacturer or the
2        manufacturer's agent; and
3            (5) the manufacturer or the manufacturer's agent
4        delivers the dialysate or devices directly to: (i) a
5        patient with end-stage renal disease, or his or her
6        designee, for the patient's self-administration of the
7        dialysis therapy or (ii) a health care provider or
8        institution for administration or delivery of the
9        dialysis therapy to a patient with end-stage renal
10        disease.
11        This paragraph (h) does not include any other drugs
12    for peritoneal dialysis, except dialysate, as described in
13    item (1) of this paragraph (h). All records of sales and
14    distribution of dialysate to patients made pursuant to
15    this paragraph (h) must be retained in accordance with
16    Section 18 of this Act.
17(Source: P.A. 100-218, eff. 8-18-17; 100-513, eff. 1-1-18;
18100-863, eff. 8-14-18; 101-420, eff. 8-16-19.)
 
19    Section 95. The Wholesale Drug Distribution Licensing Act
20is amended by changing Section 15 as follows:
 
21    (225 ILCS 120/15)  (from Ch. 111, par. 8301-15)
22    (Section scheduled to be repealed on January 1, 2023)
23    Sec. 15. Definitions. As used in this Act:
24    "Authentication" means the affirmative verification,

 

 

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1before any wholesale distribution of a prescription drug
2occurs, that each transaction listed on the pedigree has
3occurred.
4    "Authorized distributor of record" means a wholesale
5distributor with whom a manufacturer has established an
6ongoing relationship to distribute the manufacturer's
7prescription drug. An ongoing relationship is deemed to exist
8between a wholesale distributor and a manufacturer when the
9wholesale distributor, including any affiliated group of the
10wholesale distributor, as defined in Section 1504 of the
11Internal Revenue Code, complies with the following:
12        (1) The wholesale distributor has a written agreement
13    currently in effect with the manufacturer evidencing the
14    ongoing relationship; and
15        (2) The wholesale distributor is listed on the
16    manufacturer's current list of authorized distributors of
17    record, which is updated by the manufacturer on no less
18    than a monthly basis.
19    "Blood" means whole blood collected from a single donor
20and processed either for transfusion or further manufacturing.
21    "Blood component" means that part of blood separated by
22physical or mechanical means.
23    "Board" means the State Board of Pharmacy of the
24Department of Professional Regulation.
25    "Chain pharmacy warehouse" means a physical location for
26prescription drugs that acts as a central warehouse and

 

 

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1performs intracompany sales or transfers of the drugs to a
2group of chain or mail order pharmacies that have the same
3common ownership and control. Notwithstanding any other
4provision of this Act, a chain pharmacy warehouse shall be
5considered part of the normal distribution channel.
6    "Co-licensed partner or product" means an instance where
7one or more parties have the right to engage in the
8manufacturing or marketing of a prescription drug, consistent
9with the FDA's implementation of the Prescription Drug
10Marketing Act.
11    "Department" means the Department of Financial and
12Professional Regulation.
13    "Drop shipment" means the sale of a prescription drug to a
14wholesale distributor by the manufacturer of the prescription
15drug or that manufacturer's co-licensed product partner, that
16manufacturer's third party logistics provider, or that
17manufacturer's exclusive distributor or by an authorized
18distributor of record that purchased the product directly from
19the manufacturer or one of these entities whereby the
20wholesale distributor or chain pharmacy warehouse takes title
21but not physical possession of such prescription drug and the
22wholesale distributor invoices the pharmacy, chain pharmacy
23warehouse, or other person authorized by law to dispense or
24administer such drug to a patient and the pharmacy, chain
25pharmacy warehouse, or other authorized person receives
26delivery of the prescription drug directly from the

 

 

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1manufacturer, that manufacturer's third party logistics
2provider, or that manufacturer's exclusive distributor or from
3an authorized distributor of record that purchased the product
4directly from the manufacturer or one of these entities.
5    "Drug sample" means a unit of a prescription drug that is
6not intended to be sold and is intended to promote the sale of
7the drug.
8    "Facility" means a facility of a wholesale distributor
9where prescription drugs are stored, handled, repackaged, or
10offered for sale, or a facility of a third-party logistics
11provider where prescription drugs are stored or handled.
12    "FDA" means the United States Food and Drug
13Administration.
14    "Manufacturer" means a person licensed or approved by the
15FDA to engage in the manufacture of drugs or devices,
16consistent with the definition of "manufacturer" set forth in
17the FDA's regulations and guidances implementing the
18Prescription Drug Marketing Act. "Manufacturer" does not
19include anyone who is engaged in the packaging, repackaging,
20or labeling of drugs only to the extent permitted under the
21Illinois Drug Reuse Opportunity Program Act.
22    "Manufacturer's exclusive distributor" means anyone who
23contracts with a manufacturer to provide or coordinate
24warehousing, distribution, or other services on behalf of a
25manufacturer and who takes title to that manufacturer's
26prescription drug, but who does not have general

 

 

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1responsibility to direct the sale or disposition of the
2manufacturer's prescription drug. A manufacturer's exclusive
3distributor must be licensed as a wholesale distributor under
4this Act and, in order to be considered part of the normal
5distribution channel, must also be an authorized distributor
6of record.
7    "Normal distribution channel" means a chain of custody for
8a prescription drug that goes, directly or by drop shipment,
9from (i) a manufacturer of the prescription drug, (ii) that
10manufacturer to that manufacturer's co-licensed partner, (iii)
11that manufacturer to that manufacturer's third party logistics
12provider, or (iv) that manufacturer to that manufacturer's
13exclusive distributor to:
14        (1) a pharmacy or to other designated persons
15    authorized by law to dispense or administer the drug to a
16    patient;
17        (2) a wholesale distributor to a pharmacy or other
18    designated persons authorized by law to dispense or
19    administer the drug to a patient;
20        (3) a wholesale distributor to a chain pharmacy
21    warehouse to that chain pharmacy warehouse's intracompany
22    pharmacy to a patient or other designated persons
23    authorized by law to dispense or administer the drug to a
24    patient;
25        (4) a chain pharmacy warehouse to the chain pharmacy
26    warehouse's intracompany pharmacy or other designated

 

 

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1    persons authorized by law to dispense or administer the
2    drug to the patient;
3        (5) an authorized distributor of record to one other
4    authorized distributor of record to an office-based health
5    care practitioner authorized by law to dispense or
6    administer the drug to the patient; or
7        (6) an authorized distributor to a pharmacy or other
8    persons licensed to dispense or administer the drug.
9    "Pedigree" means a document or electronic file containing
10information that records each wholesale distribution of any
11given prescription drug from the point of origin to the final
12wholesale distribution point of any given prescription drug.
13    "Person" means and includes a natural person, partnership,
14association, corporation, or any other legal business entity.
15    "Pharmacy distributor" means any pharmacy licensed in this
16State or hospital pharmacy that is engaged in the delivery or
17distribution of prescription drugs either to any other
18pharmacy licensed in this State or to any other person or
19entity including, but not limited to, a wholesale drug
20distributor engaged in the delivery or distribution of
21prescription drugs who is involved in the actual,
22constructive, or attempted transfer of a drug in this State to
23other than the ultimate consumer except as otherwise provided
24for by law.
25    "Prescription drug" means any human drug, including any
26biological product (except for blood and blood components

 

 

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1intended for transfusion or biological products that are also
2medical devices), required by federal law or regulation to be
3dispensed only by a prescription, including finished dosage
4forms and bulk drug substances subject to Section 503 of the
5Federal Food, Drug and Cosmetic Act.
6    "Repackage" means repackaging or otherwise changing the
7container, wrapper, or labeling to further the distribution of
8a prescription drug, excluding that completed by the
9pharmacist responsible for dispensing the product to a
10patient.
11    "Secretary" means the Secretary of Financial and
12Professional Regulation.
13    "Third-party logistics provider" means anyone who
14contracts with a prescription drug manufacturer to provide or
15coordinate warehousing, distribution, or other services on
16behalf of a manufacturer, but does not take title to the
17prescription drug or have general responsibility to direct the
18prescription drug's sale or disposition.
19    "Wholesale distribution" means the distribution of
20prescription drugs to persons other than a consumer or
21patient, but does not include any of the following:
22        (1) Intracompany sales of prescription drugs, meaning
23    (i) any transaction or transfer between any division,
24    subsidiary, parent, or affiliated or related company under
25    the common ownership and control of a corporate entity or
26    (ii) any transaction or transfer between co-licensees of a

 

 

HB0119 Enrolled- 20 -LRB102 04093 CPF 14109 b

1    co-licensed product.
2        (2) The sale, purchase, distribution, trade, or
3    transfer of a prescription drug or offer to sell,
4    purchase, distribute, trade, or transfer a prescription
5    drug for emergency medical reasons.
6        (3) The distribution of prescription drug samples by
7    manufacturers' representatives.
8        (4) Drug returns, when conducted by a hospital, health
9    care entity, or charitable institution in accordance with
10    federal regulation.
11        (5) The sale of minimal quantities of prescription
12    drugs by licensed pharmacies to licensed practitioners for
13    office use or other licensed pharmacies.
14        (6) The sale, purchase, or trade of a drug, an offer to
15    sell, purchase, or trade a drug, or the dispensing of a
16    drug pursuant to a prescription.
17        (7) The sale, transfer, merger, or consolidation of
18    all or part of the business of a pharmacy or pharmacies
19    from or with another pharmacy or pharmacies, whether
20    accomplished as a purchase and sale of stock or business
21    assets.
22        (8) The sale, purchase, distribution, trade, or
23    transfer of a prescription drug from one authorized
24    distributor of record to one additional authorized
25    distributor of record when the manufacturer has stated in
26    writing to the receiving authorized distributor of record

 

 

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1    that the manufacturer is unable to supply the prescription
2    drug and the supplying authorized distributor of record
3    states in writing that the prescription drug being
4    supplied had until that time been exclusively in the
5    normal distribution channel.
6        (9) The delivery of or the offer to deliver a
7    prescription drug by a common carrier solely in the common
8    carrier's usual course of business of transporting
9    prescription drugs when the common carrier does not store,
10    warehouse, or take legal ownership of the prescription
11    drug.
12        (10) The sale or transfer from a retail pharmacy, mail
13    order pharmacy, or chain pharmacy warehouse of expired,
14    damaged, returned, or recalled prescription drugs to the
15    original manufacturer, the originating wholesale
16    distributor, or a third party returns processor.
17        (11) The donation of drugs to the extent permitted
18    under the Illinois Drug Reuse Opportunity Program Act.
19    "Wholesale drug distributor" means anyone engaged in the
20wholesale distribution of prescription drugs into, out of, or
21within the State, including without limitation manufacturers;
22repackers; own label distributors; jobbers; private label
23distributors; brokers; warehouses, including manufacturers'
24and distributors' warehouses; manufacturer's exclusive
25distributors; and authorized distributors of record; drug
26wholesalers or distributors; independent wholesale drug

 

 

HB0119 Enrolled- 22 -LRB102 04093 CPF 14109 b

1traders; specialty wholesale distributors; and retail
2pharmacies that conduct wholesale distribution; and chain
3pharmacy warehouses that conduct wholesale distribution. In
4order to be considered part of the normal distribution
5channel, a wholesale distributor must also be an authorized
6distributor of record.
7(Source: P.A. 101-420, eff. 8-16-19.)
 
8    Section 100. The Senior Pharmaceutical Assistance Act is
9amended by changing Section 10 as follows:
 
10    (320 ILCS 50/10)
11    Sec. 10. Definitions. In this Act:
12    "Manufacturer" includes:
13        (1) An entity that is engaged in (a) the production,
14    preparation, propagation, compounding, conversion, or
15    processing of prescription drug products (i) directly or
16    indirectly by extraction from substances of natural
17    origin, (ii) independently by means of chemical synthesis,
18    or (iii) by combination of extraction and chemical
19    synthesis; or (b) the packaging, repackaging, labeling or
20    re-labeling, or distribution of prescription drug
21    products.
22        (2) The entity holding legal title to or possession of
23    the national drug code number for the covered prescription
24    drug.

 

 

HB0119 Enrolled- 23 -LRB102 04093 CPF 14109 b

1    The term does not include a wholesale distributor of
2drugs, drugstore chain organization, or retail pharmacy
3licensed by the State. The term also does not include anyone
4who is engaged in the packaging, repackaging, or labeling of
5drugs only to the extent permitted under the Illinois Drug
6Reuse Opportunity Program Act.
7    "Prescription drug" means a drug that may be dispensed
8only upon prescription by an authorized prescriber and that is
9approved for safety and effectiveness as a prescription drug
10under Section 505 or 507 of the Federal Food, Drug and Cosmetic
11Act.
12    "Senior citizen" or "senior" means a person 65 years of
13age or older.
14(Source: P.A. 92-594, eff. 6-27-02.)
 
15    Section 105. The Illinois Food, Drug and Cosmetic Act is
16amended by changing Section 16 as follows:
 
17    (410 ILCS 620/16)  (from Ch. 56 1/2, par. 516)
18    Sec. 16. (a) The Director is hereby authorized to
19promulgate regulations exempting from any labeling or
20packaging requirement of this Act drugs and devices which are
21(i) , in accordance with the practice of the trade, to be
22processed, labeled or repacked in substantial quantities at
23establishments other than those where originally processed or
24packaged on condition that such drugs and devices are not

 

 

HB0119 Enrolled- 24 -LRB102 04093 CPF 14109 b

1adulterated or misbranded under the provisions of this Act
2upon removal from such processing, labeling or repacking
3establishment or (ii) packaged, repackaged, or labeled to the
4extent permitted under the Illinois Drug Reuse Opportunity
5Program Act.
6    (b) Drugs and device labeling or packaging exemptions
7adopted under the Federal Act and supplements thereto or
8revisions thereof shall apply to drugs and devices in Illinois
9except insofar as modified or rejected by regulations
10promulgated by the Director.
11    (c) A drug intended for use by man which (A) is a
12habit-forming drug to which Section 15 (d) applies; or (B)
13because of its toxicity or other potentiality for harmful
14effect or the method of its use or the collateral measures
15necessary to its use is not safe for use except under the
16supervision of a practitioner licensed by law to administer
17such drug; or (C) is limited by an approved application under
18Section 505 of the Federal Act or Section 17 of this Act to use
19under the professional supervision of a practitioner licensed
20by law to administer such drug, shall be dispensed only in
21accordance with the provisions of the "Illinois Controlled
22Substances Act". The act of dispensing a drug contrary to the
23provisions of this paragraph shall be deemed to be an act which
24results in a drug being misbranded while held for sale.
25    (d) Any drug dispensed by filling or refilling a written
26or oral prescription of a practitioner licensed by law to

 

 

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1administer such drug shall be exempt from the requirements of
2Section 15, except subsections (a), (k) and (l) and clauses
3(2) and (3) of subsection (i), and the packaging requirements
4of subsections (g), (h) and (q), if the drug bears a label
5containing the proprietary name or names, or if there is none,
6the established name or names of the drugs, the dosage and
7quantity, unless the prescribing practitioner, in the interest
8of the health of the patient, directs otherwise in writing,
9the name and address of the dispenser, the serial number and
10date of the prescription or of its filling, the name of the
11prescriber and, if stated in the prescription, the name of the
12patient, and the directions for use and the cautionary
13statements, if any, contained in such prescription. This
14exemption shall not apply to any drug dispensed in the course
15of the conduct of business of dispensing drugs pursuant to
16diagnosis by mail, or to a drug dispensed in violation of
17subsection (a) of this Section.
18    (e) The Director may by regulation remove drugs subject to
19Section 15 (d) and Section 17 from the requirements of
20subsection (c) of this Section when such requirements are not
21necessary for the protection of the public health.
22    (f) A drug which is subject to subsection (c) of this
23Section shall be deemed to be misbranded if at any time before
24dispensing its label fails to bear the statement "Caution:
25Federal Law Prohibits Dispensing Without Prescription" or
26"Caution: State Law Prohibits Dispensing Without

 

 

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1Prescription". A drug to which subsection (c) of this Section
2does not apply shall be deemed to be misbranded if at any time
3prior to dispensing its label bears the caution statement
4quoted in the preceding sentence.
5    (g) Nothing in this Section shall be construed to relieve
6any person from any requirement prescribed by or under
7authority of law with respect to controlled substances now
8included or which may hereafter be included within the
9classifications of controlled substances cannabis as defined
10in applicable Federal laws relating to controlled substances
11or cannabis or the Cannabis Control Act.
12(Source: P.A. 84-1308.)
 
13    Section 110. The Illinois Controlled Substances Act is
14amended by changing Section 102 as follows:
 
15    (720 ILCS 570/102)  (from Ch. 56 1/2, par. 1102)
16    Sec. 102. Definitions. As used in this Act, unless the
17context otherwise requires:
18    (a) "Addict" means any person who habitually uses any
19drug, chemical, substance or dangerous drug other than alcohol
20so as to endanger the public morals, health, safety or welfare
21or who is so far addicted to the use of a dangerous drug or
22controlled substance other than alcohol as to have lost the
23power of self control with reference to his or her addiction.
24    (b) "Administer" means the direct application of a

 

 

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1controlled substance, whether by injection, inhalation,
2ingestion, or any other means, to the body of a patient,
3research subject, or animal (as defined by the Humane
4Euthanasia in Animal Shelters Act) by:
5        (1) a practitioner (or, in his or her presence, by his
6    or her authorized agent),
7        (2) the patient or research subject pursuant to an
8    order, or
9        (3) a euthanasia technician as defined by the Humane
10    Euthanasia in Animal Shelters Act.
11    (c) "Agent" means an authorized person who acts on behalf
12of or at the direction of a manufacturer, distributor,
13dispenser, prescriber, or practitioner. It does not include a
14common or contract carrier, public warehouseman or employee of
15the carrier or warehouseman.
16    (c-1) "Anabolic Steroids" means any drug or hormonal
17substance, chemically and pharmacologically related to
18testosterone (other than estrogens, progestins,
19corticosteroids, and dehydroepiandrosterone), and includes:
20    (i) 3[beta],17-dihydroxy-5a-androstane, 
21    (ii) 3[alpha],17[beta]-dihydroxy-5a-androstane, 
22    (iii) 5[alpha]-androstan-3,17-dione, 
23    (iv) 1-androstenediol (3[beta], 
24        17[beta]-dihydroxy-5[alpha]-androst-1-ene), 
25    (v) 1-androstenediol (3[alpha], 
26        17[beta]-dihydroxy-5[alpha]-androst-1-ene), 

 

 

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1    (vi) 4-androstenediol  
2        (3[beta],17[beta]-dihydroxy-androst-4-ene), 
3    (vii) 5-androstenediol  
4        (3[beta],17[beta]-dihydroxy-androst-5-ene), 
5    (viii) 1-androstenedione  
6        ([5alpha]-androst-1-en-3,17-dione), 
7    (ix) 4-androstenedione  
8        (androst-4-en-3,17-dione), 
9    (x) 5-androstenedione  
10        (androst-5-en-3,17-dione), 
11    (xi) bolasterone (7[alpha],17a-dimethyl-17[beta]- 
12        hydroxyandrost-4-en-3-one), 
13    (xii) boldenone (17[beta]-hydroxyandrost- 
14        1,4,-diene-3-one), 
15    (xiii) boldione (androsta-1,4- 
16        diene-3,17-dione), 
17    (xiv) calusterone (7[beta],17[alpha]-dimethyl-17 
18        [beta]-hydroxyandrost-4-en-3-one), 
19    (xv) clostebol (4-chloro-17[beta]- 
20        hydroxyandrost-4-en-3-one), 
21    (xvi) dehydrochloromethyltestosterone (4-chloro- 
22        17[beta]-hydroxy-17[alpha]-methyl- 
23        androst-1,4-dien-3-one), 
24    (xvii) desoxymethyltestosterone 
25    (17[alpha]-methyl-5[alpha] 
26        -androst-2-en-17[beta]-ol)(a.k.a., madol), 

 

 

HB0119 Enrolled- 29 -LRB102 04093 CPF 14109 b

1    (xviii) [delta]1-dihydrotestosterone (a.k.a.  
2        '1-testosterone') (17[beta]-hydroxy- 
3        5[alpha]-androst-1-en-3-one), 
4    (xix) 4-dihydrotestosterone (17[beta]-hydroxy- 
5        androstan-3-one), 
6    (xx) drostanolone (17[beta]-hydroxy-2[alpha]-methyl- 
7        5[alpha]-androstan-3-one), 
8    (xxi) ethylestrenol (17[alpha]-ethyl-17[beta]- 
9        hydroxyestr-4-ene), 
10    (xxii) fluoxymesterone (9-fluoro-17[alpha]-methyl- 
11        1[beta],17[beta]-dihydroxyandrost-4-en-3-one), 
12    (xxiii) formebolone (2-formyl-17[alpha]-methyl-11[alpha], 
13        17[beta]-dihydroxyandrost-1,4-dien-3-one), 
14    (xxiv) furazabol (17[alpha]-methyl-17[beta]- 
15        hydroxyandrostano[2,3-c]-furazan), 
16    (xxv) 13[beta]-ethyl-17[beta]-hydroxygon-4-en-3-one, 
17    (xxvi) 4-hydroxytestosterone (4,17[beta]-dihydroxy- 
18        androst-4-en-3-one), 
19    (xxvii) 4-hydroxy-19-nortestosterone (4,17[beta]- 
20        dihydroxy-estr-4-en-3-one), 
21    (xxviii) mestanolone (17[alpha]-methyl-17[beta]- 
22        hydroxy-5-androstan-3-one), 
23    (xxix) mesterolone (1amethyl-17[beta]-hydroxy- 
24        [5a]-androstan-3-one), 
25    (xxx) methandienone (17[alpha]-methyl-17[beta]- 
26        hydroxyandrost-1,4-dien-3-one), 

 

 

HB0119 Enrolled- 30 -LRB102 04093 CPF 14109 b

1    (xxxi) methandriol (17[alpha]-methyl-3[beta],17[beta]- 
2        dihydroxyandrost-5-ene), 
3    (xxxii) methenolone (1-methyl-17[beta]-hydroxy- 
4        5[alpha]-androst-1-en-3-one), 
5    (xxxiii) 17[alpha]-methyl-3[beta], 17[beta]- 
6        dihydroxy-5a-androstane, 
7    (xxxiv) 17[alpha]-methyl-3[alpha],17[beta]-dihydroxy 
8        -5a-androstane, 
9    (xxxv) 17[alpha]-methyl-3[beta],17[beta]- 
10        dihydroxyandrost-4-ene), 
11    (xxxvi) 17[alpha]-methyl-4-hydroxynandrolone (17[alpha]- 
12        methyl-4-hydroxy-17[beta]-hydroxyestr-4-en-3-one), 
13    (xxxvii) methyldienolone (17[alpha]-methyl-17[beta]- 
14        hydroxyestra-4,9(10)-dien-3-one), 
15    (xxxviii) methyltrienolone (17[alpha]-methyl-17[beta]- 
16        hydroxyestra-4,9-11-trien-3-one), 
17    (xxxix) methyltestosterone (17[alpha]-methyl-17[beta]- 
18        hydroxyandrost-4-en-3-one), 
19    (xl) mibolerone (7[alpha],17a-dimethyl-17[beta]- 
20        hydroxyestr-4-en-3-one), 
21    (xli) 17[alpha]-methyl-[delta]1-dihydrotestosterone  
22        (17b[beta]-hydroxy-17[alpha]-methyl-5[alpha]- 
23        androst-1-en-3-one)(a.k.a. '17-[alpha]-methyl- 
24        1-testosterone'), 
25    (xlii) nandrolone (17[beta]-hydroxyestr-4-en-3-one), 
26    (xliii) 19-nor-4-androstenediol (3[beta], 17[beta]- 

 

 

HB0119 Enrolled- 31 -LRB102 04093 CPF 14109 b

1        dihydroxyestr-4-ene), 
2    (xliv) 19-nor-4-androstenediol (3[alpha], 17[beta]- 
3        dihydroxyestr-4-ene), 
4    (xlv) 19-nor-5-androstenediol (3[beta], 17[beta]- 
5        dihydroxyestr-5-ene), 
6    (xlvi) 19-nor-5-androstenediol (3[alpha], 17[beta]- 
7        dihydroxyestr-5-ene), 
8    (xlvii) 19-nor-4,9(10)-androstadienedione  
9        (estra-4,9(10)-diene-3,17-dione), 
10    (xlviii) 19-nor-4-androstenedione (estr-4- 
11        en-3,17-dione), 
12    (xlix) 19-nor-5-androstenedione (estr-5- 
13        en-3,17-dione), 
14    (l) norbolethone (13[beta], 17a-diethyl-17[beta]- 
15        hydroxygon-4-en-3-one), 
16    (li) norclostebol (4-chloro-17[beta]- 
17        hydroxyestr-4-en-3-one), 
18    (lii) norethandrolone (17[alpha]-ethyl-17[beta]- 
19        hydroxyestr-4-en-3-one), 
20    (liii) normethandrolone (17[alpha]-methyl-17[beta]- 
21        hydroxyestr-4-en-3-one), 
22    (liv) oxandrolone (17[alpha]-methyl-17[beta]-hydroxy- 
23        2-oxa-5[alpha]-androstan-3-one), 
24    (lv) oxymesterone (17[alpha]-methyl-4,17[beta]- 
25        dihydroxyandrost-4-en-3-one), 
26    (lvi) oxymetholone (17[alpha]-methyl-2-hydroxymethylene- 

 

 

HB0119 Enrolled- 32 -LRB102 04093 CPF 14109 b

1        17[beta]-hydroxy-(5[alpha]-androstan-3-one), 
2    (lvii) stanozolol (17[alpha]-methyl-17[beta]-hydroxy- 
3        (5[alpha]-androst-2-eno[3,2-c]-pyrazole), 
4    (lviii) stenbolone (17[beta]-hydroxy-2-methyl- 
5        (5[alpha]-androst-1-en-3-one), 
6    (lix) testolactone (13-hydroxy-3-oxo-13,17- 
7        secoandrosta-1,4-dien-17-oic 
8        acid lactone), 
9    (lx) testosterone (17[beta]-hydroxyandrost- 
10        4-en-3-one), 
11    (lxi) tetrahydrogestrinone (13[beta], 17[alpha]- 
12        diethyl-17[beta]-hydroxygon- 
13        4,9,11-trien-3-one), 
14    (lxii) trenbolone (17[beta]-hydroxyestr-4,9, 
15        11-trien-3-one). 
16    Any person who is otherwise lawfully in possession of an
17anabolic steroid, or who otherwise lawfully manufactures,
18distributes, dispenses, delivers, or possesses with intent to
19deliver an anabolic steroid, which anabolic steroid is
20expressly intended for and lawfully allowed to be administered
21through implants to livestock or other nonhuman species, and
22which is approved by the Secretary of Health and Human
23Services for such administration, and which the person intends
24to administer or have administered through such implants,
25shall not be considered to be in unauthorized possession or to
26unlawfully manufacture, distribute, dispense, deliver, or

 

 

HB0119 Enrolled- 33 -LRB102 04093 CPF 14109 b

1possess with intent to deliver such anabolic steroid for
2purposes of this Act.
3    (d) "Administration" means the Drug Enforcement
4Administration, United States Department of Justice, or its
5successor agency.
6    (d-5) "Clinical Director, Prescription Monitoring Program"
7means a Department of Human Services administrative employee
8licensed to either prescribe or dispense controlled substances
9who shall run the clinical aspects of the Department of Human
10Services Prescription Monitoring Program and its Prescription
11Information Library.
12    (d-10) "Compounding" means the preparation and mixing of
13components, excluding flavorings, (1) as the result of a
14prescriber's prescription drug order or initiative based on
15the prescriber-patient-pharmacist relationship in the course
16of professional practice or (2) for the purpose of, or
17incident to, research, teaching, or chemical analysis and not
18for sale or dispensing. "Compounding" includes the preparation
19of drugs or devices in anticipation of receiving prescription
20drug orders based on routine, regularly observed dispensing
21patterns. Commercially available products may be compounded
22for dispensing to individual patients only if both of the
23following conditions are met: (i) the commercial product is
24not reasonably available from normal distribution channels in
25a timely manner to meet the patient's needs and (ii) the
26prescribing practitioner has requested that the drug be

 

 

HB0119 Enrolled- 34 -LRB102 04093 CPF 14109 b

1compounded.
2    (e) "Control" means to add a drug or other substance, or
3immediate precursor, to a Schedule whether by transfer from
4another Schedule or otherwise.
5    (f) "Controlled Substance" means (i) a drug, substance,
6immediate precursor, or synthetic drug in the Schedules of
7Article II of this Act or (ii) a drug or other substance, or
8immediate precursor, designated as a controlled substance by
9the Department through administrative rule. The term does not
10include distilled spirits, wine, malt beverages, or tobacco,
11as those terms are defined or used in the Liquor Control Act of
121934 and the Tobacco Products Tax Act of 1995.
13    (f-5) "Controlled substance analog" means a substance:
14        (1) the chemical structure of which is substantially
15    similar to the chemical structure of a controlled
16    substance in Schedule I or II;
17        (2) which has a stimulant, depressant, or
18    hallucinogenic effect on the central nervous system that
19    is substantially similar to or greater than the stimulant,
20    depressant, or hallucinogenic effect on the central
21    nervous system of a controlled substance in Schedule I or
22    II; or
23        (3) with respect to a particular person, which such
24    person represents or intends to have a stimulant,
25    depressant, or hallucinogenic effect on the central
26    nervous system that is substantially similar to or greater

 

 

HB0119 Enrolled- 35 -LRB102 04093 CPF 14109 b

1    than the stimulant, depressant, or hallucinogenic effect
2    on the central nervous system of a controlled substance in
3    Schedule I or II.
4    (g) "Counterfeit substance" means a controlled substance,
5which, or the container or labeling of which, without
6authorization bears the trademark, trade name, or other
7identifying mark, imprint, number or device, or any likeness
8thereof, of a manufacturer, distributor, or dispenser other
9than the person who in fact manufactured, distributed, or
10dispensed the substance.
11    (h) "Deliver" or "delivery" means the actual, constructive
12or attempted transfer of possession of a controlled substance,
13with or without consideration, whether or not there is an
14agency relationship. "Deliver" or "delivery" does not include
15the donation of drugs to the extent permitted under the
16Illinois Drug Reuse Opportunity Program Act.
17    (i) "Department" means the Illinois Department of Human
18Services (as successor to the Department of Alcoholism and
19Substance Abuse) or its successor agency.
20    (j) (Blank).
21    (k) "Department of Corrections" means the Department of
22Corrections of the State of Illinois or its successor agency.
23    (l) "Department of Financial and Professional Regulation"
24means the Department of Financial and Professional Regulation
25of the State of Illinois or its successor agency.
26    (m) "Depressant" means any drug that (i) causes an overall

 

 

HB0119 Enrolled- 36 -LRB102 04093 CPF 14109 b

1depression of central nervous system functions, (ii) causes
2impaired consciousness and awareness, and (iii) can be
3habit-forming or lead to a substance abuse problem, including
4but not limited to alcohol, cannabis and its active principles
5and their analogs, benzodiazepines and their analogs,
6barbiturates and their analogs, opioids (natural and
7synthetic) and their analogs, and chloral hydrate and similar
8sedative hypnotics.
9    (n) (Blank).
10    (o) "Director" means the Director of the Illinois State
11Police or his or her designated agents.
12    (p) "Dispense" means to deliver a controlled substance to
13an ultimate user or research subject by or pursuant to the
14lawful order of a prescriber, including the prescribing,
15administering, packaging, labeling, or compounding necessary
16to prepare the substance for that delivery.
17    (q) "Dispenser" means a practitioner who dispenses.
18    (r) "Distribute" means to deliver, other than by
19administering or dispensing, a controlled substance.
20    (s) "Distributor" means a person who distributes.
21    (t) "Drug" means (1) substances recognized as drugs in the
22official United States Pharmacopoeia, Official Homeopathic
23Pharmacopoeia of the United States, or official National
24Formulary, or any supplement to any of them; (2) substances
25intended for use in diagnosis, cure, mitigation, treatment, or
26prevention of disease in man or animals; (3) substances (other

 

 

HB0119 Enrolled- 37 -LRB102 04093 CPF 14109 b

1than food) intended to affect the structure of any function of
2the body of man or animals and (4) substances intended for use
3as a component of any article specified in clause (1), (2), or
4(3) of this subsection. It does not include devices or their
5components, parts, or accessories.
6    (t-3) "Electronic health record" or "EHR" means an
7electronic record of health-related information on an
8individual that is created, gathered, managed, and consulted
9by authorized health care clinicians and staff.
10    (t-4) "Emergency medical services personnel" has the
11meaning ascribed to it in the Emergency Medical Services (EMS)
12Systems Act.
13    (t-5) "Euthanasia agency" means an entity certified by the
14Department of Financial and Professional Regulation for the
15purpose of animal euthanasia that holds an animal control
16facility license or animal shelter license under the Animal
17Welfare Act. A euthanasia agency is authorized to purchase,
18store, possess, and utilize Schedule II nonnarcotic and
19Schedule III nonnarcotic drugs for the sole purpose of animal
20euthanasia.
21    (t-10) "Euthanasia drugs" means Schedule II or Schedule
22III substances (nonnarcotic controlled substances) that are
23used by a euthanasia agency for the purpose of animal
24euthanasia.
25    (u) "Good faith" means the prescribing or dispensing of a
26controlled substance by a practitioner in the regular course

 

 

HB0119 Enrolled- 38 -LRB102 04093 CPF 14109 b

1of professional treatment to or for any person who is under his
2or her treatment for a pathology or condition other than that
3individual's physical or psychological dependence upon or
4addiction to a controlled substance, except as provided
5herein: and application of the term to a pharmacist shall mean
6the dispensing of a controlled substance pursuant to the
7prescriber's order which in the professional judgment of the
8pharmacist is lawful. The pharmacist shall be guided by
9accepted professional standards including, but not limited to
10the following, in making the judgment:
11        (1) lack of consistency of prescriber-patient
12    relationship,
13        (2) frequency of prescriptions for same drug by one
14    prescriber for large numbers of patients,
15        (3) quantities beyond those normally prescribed,
16        (4) unusual dosages (recognizing that there may be
17    clinical circumstances where more or less than the usual
18    dose may be used legitimately),
19        (5) unusual geographic distances between patient,
20    pharmacist and prescriber,
21        (6) consistent prescribing of habit-forming drugs.
22    (u-0.5) "Hallucinogen" means a drug that causes markedly
23altered sensory perception leading to hallucinations of any
24type.
25    (u-1) "Home infusion services" means services provided by
26a pharmacy in compounding solutions for direct administration

 

 

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1to a patient in a private residence, long-term care facility,
2or hospice setting by means of parenteral, intravenous,
3intramuscular, subcutaneous, or intraspinal infusion.
4    (u-5) "Illinois State Police" means the State Police of
5the State of Illinois, or its successor agency.
6    (v) "Immediate precursor" means a substance:
7        (1) which the Department has found to be and by rule
8    designated as being a principal compound used, or produced
9    primarily for use, in the manufacture of a controlled
10    substance;
11        (2) which is an immediate chemical intermediary used
12    or likely to be used in the manufacture of such controlled
13    substance; and
14        (3) the control of which is necessary to prevent,
15    curtail or limit the manufacture of such controlled
16    substance.
17    (w) "Instructional activities" means the acts of teaching,
18educating or instructing by practitioners using controlled
19substances within educational facilities approved by the State
20Board of Education or its successor agency.
21    (x) "Local authorities" means a duly organized State,
22County or Municipal peace unit or police force.
23    (y) "Look-alike substance" means a substance, other than a
24controlled substance which (1) by overall dosage unit
25appearance, including shape, color, size, markings or lack
26thereof, taste, consistency, or any other identifying physical

 

 

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1characteristic of the substance, would lead a reasonable
2person to believe that the substance is a controlled
3substance, or (2) is expressly or impliedly represented to be
4a controlled substance or is distributed under circumstances
5which would lead a reasonable person to believe that the
6substance is a controlled substance. For the purpose of
7determining whether the representations made or the
8circumstances of the distribution would lead a reasonable
9person to believe the substance to be a controlled substance
10under this clause (2) of subsection (y), the court or other
11authority may consider the following factors in addition to
12any other factor that may be relevant:
13        (a) statements made by the owner or person in control
14    of the substance concerning its nature, use or effect;
15        (b) statements made to the buyer or recipient that the
16    substance may be resold for profit;
17        (c) whether the substance is packaged in a manner
18    normally used for the illegal distribution of controlled
19    substances;
20        (d) whether the distribution or attempted distribution
21    included an exchange of or demand for money or other
22    property as consideration, and whether the amount of the
23    consideration was substantially greater than the
24    reasonable retail market value of the substance.
25    Clause (1) of this subsection (y) shall not apply to a
26noncontrolled substance in its finished dosage form that was

 

 

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1initially introduced into commerce prior to the initial
2introduction into commerce of a controlled substance in its
3finished dosage form which it may substantially resemble.
4    Nothing in this subsection (y) prohibits the dispensing or
5distributing of noncontrolled substances by persons authorized
6to dispense and distribute controlled substances under this
7Act, provided that such action would be deemed to be carried
8out in good faith under subsection (u) if the substances
9involved were controlled substances.
10    Nothing in this subsection (y) or in this Act prohibits
11the manufacture, preparation, propagation, compounding,
12processing, packaging, advertising or distribution of a drug
13or drugs by any person registered pursuant to Section 510 of
14the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360).
15    (y-1) "Mail-order pharmacy" means a pharmacy that is
16located in a state of the United States that delivers,
17dispenses or distributes, through the United States Postal
18Service or other common carrier, to Illinois residents, any
19substance which requires a prescription.
20    (z) "Manufacture" means the production, preparation,
21propagation, compounding, conversion or processing of a
22controlled substance other than methamphetamine, either
23directly or indirectly, by extraction from substances of
24natural origin, or independently by means of chemical
25synthesis, or by a combination of extraction and chemical
26synthesis, and includes any packaging or repackaging of the

 

 

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1substance or labeling of its container, except that this term
2does not include:
3        (1) by an ultimate user, the preparation or
4    compounding of a controlled substance for his or her own
5    use; or
6        (2) by a practitioner, or his or her authorized agent
7    under his or her supervision, the preparation,
8    compounding, packaging, or labeling of a controlled
9    substance:
10            (a) as an incident to his or her administering or
11        dispensing of a controlled substance in the course of
12        his or her professional practice; or
13            (b) as an incident to lawful research, teaching or
14        chemical analysis and not for sale; or .
15        (3) the packaging, repackaging, or labeling of drugs
16    only to the extent permitted under the Illinois Drug Reuse
17    Opportunity Program Act.
18    (z-1) (Blank).
19    (z-5) "Medication shopping" means the conduct prohibited
20under subsection (a) of Section 314.5 of this Act.
21    (z-10) "Mid-level practitioner" means (i) a physician
22assistant who has been delegated authority to prescribe
23through a written delegation of authority by a physician
24licensed to practice medicine in all of its branches, in
25accordance with Section 7.5 of the Physician Assistant
26Practice Act of 1987, (ii) an advanced practice registered

 

 

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1nurse who has been delegated authority to prescribe through a
2written delegation of authority by a physician licensed to
3practice medicine in all of its branches or by a podiatric
4physician, in accordance with Section 65-40 of the Nurse
5Practice Act, (iii) an advanced practice registered nurse
6certified as a nurse practitioner, nurse midwife, or clinical
7nurse specialist who has been granted authority to prescribe
8by a hospital affiliate in accordance with Section 65-45 of
9the Nurse Practice Act, (iv) an animal euthanasia agency, or
10(v) a prescribing psychologist.
11    (aa) "Narcotic drug" means any of the following, whether
12produced directly or indirectly by extraction from substances
13of vegetable origin, or independently by means of chemical
14synthesis, or by a combination of extraction and chemical
15synthesis:
16        (1) opium, opiates, derivatives of opium and opiates,
17    including their isomers, esters, ethers, salts, and salts
18    of isomers, esters, and ethers, whenever the existence of
19    such isomers, esters, ethers, and salts is possible within
20    the specific chemical designation; however the term
21    "narcotic drug" does not include the isoquinoline
22    alkaloids of opium;
23        (2) (blank);
24        (3) opium poppy and poppy straw;
25        (4) coca leaves, except coca leaves and extracts of
26    coca leaves from which substantially all of the cocaine

 

 

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1    and ecgonine, and their isomers, derivatives and salts,
2    have been removed;
3        (5) cocaine, its salts, optical and geometric isomers,
4    and salts of isomers;
5        (6) ecgonine, its derivatives, their salts, isomers,
6    and salts of isomers;
7        (7) any compound, mixture, or preparation which
8    contains any quantity of any of the substances referred to
9    in subparagraphs (1) through (6).
10    (bb) "Nurse" means a registered nurse licensed under the
11Nurse Practice Act.
12    (cc) (Blank).
13    (dd) "Opiate" means any substance having an addiction
14forming or addiction sustaining liability similar to morphine
15or being capable of conversion into a drug having addiction
16forming or addiction sustaining liability.
17    (ee) "Opium poppy" means the plant of the species Papaver
18somniferum L., except its seeds.
19    (ee-5) "Oral dosage" means a tablet, capsule, elixir, or
20solution or other liquid form of medication intended for
21administration by mouth, but the term does not include a form
22of medication intended for buccal, sublingual, or transmucosal
23administration.
24    (ff) "Parole and Pardon Board" means the Parole and Pardon
25Board of the State of Illinois or its successor agency.
26    (gg) "Person" means any individual, corporation,

 

 

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1mail-order pharmacy, government or governmental subdivision or
2agency, business trust, estate, trust, partnership or
3association, or any other entity.
4    (hh) "Pharmacist" means any person who holds a license or
5certificate of registration as a registered pharmacist, a
6local registered pharmacist or a registered assistant
7pharmacist under the Pharmacy Practice Act.
8    (ii) "Pharmacy" means any store, ship or other place in
9which pharmacy is authorized to be practiced under the
10Pharmacy Practice Act.
11    (ii-5) "Pharmacy shopping" means the conduct prohibited
12under subsection (b) of Section 314.5 of this Act.
13    (ii-10) "Physician" (except when the context otherwise
14requires) means a person licensed to practice medicine in all
15of its branches.
16    (jj) "Poppy straw" means all parts, except the seeds, of
17the opium poppy, after mowing.
18    (kk) "Practitioner" means a physician licensed to practice
19medicine in all its branches, dentist, optometrist, podiatric
20physician, veterinarian, scientific investigator, pharmacist,
21physician assistant, advanced practice registered nurse,
22licensed practical nurse, registered nurse, emergency medical
23services personnel, hospital, laboratory, or pharmacy, or
24other person licensed, registered, or otherwise lawfully
25permitted by the United States or this State to distribute,
26dispense, conduct research with respect to, administer or use

 

 

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1in teaching or chemical analysis, a controlled substance in
2the course of professional practice or research.
3    (ll) "Pre-printed prescription" means a written
4prescription upon which the designated drug has been indicated
5prior to the time of issuance; the term does not mean a written
6prescription that is individually generated by machine or
7computer in the prescriber's office.
8    (mm) "Prescriber" means a physician licensed to practice
9medicine in all its branches, dentist, optometrist,
10prescribing psychologist licensed under Section 4.2 of the
11Clinical Psychologist Licensing Act with prescriptive
12authority delegated under Section 4.3 of the Clinical
13Psychologist Licensing Act, podiatric physician, or
14veterinarian who issues a prescription, a physician assistant
15who issues a prescription for a controlled substance in
16accordance with Section 303.05, a written delegation, and a
17written collaborative agreement required under Section 7.5 of
18the Physician Assistant Practice Act of 1987, an advanced
19practice registered nurse with prescriptive authority
20delegated under Section 65-40 of the Nurse Practice Act and in
21accordance with Section 303.05, a written delegation, and a
22written collaborative agreement under Section 65-35 of the
23Nurse Practice Act, an advanced practice registered nurse
24certified as a nurse practitioner, nurse midwife, or clinical
25nurse specialist who has been granted authority to prescribe
26by a hospital affiliate in accordance with Section 65-45 of

 

 

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1the Nurse Practice Act and in accordance with Section 303.05,
2or an advanced practice registered nurse certified as a nurse
3practitioner, nurse midwife, or clinical nurse specialist who
4has full practice authority pursuant to Section 65-43 of the
5Nurse Practice Act.
6    (nn) "Prescription" means a written, facsimile, or oral
7order, or an electronic order that complies with applicable
8federal requirements, of a physician licensed to practice
9medicine in all its branches, dentist, podiatric physician or
10veterinarian for any controlled substance, of an optometrist
11in accordance with Section 15.1 of the Illinois Optometric
12Practice Act of 1987, of a prescribing psychologist licensed
13under Section 4.2 of the Clinical Psychologist Licensing Act
14with prescriptive authority delegated under Section 4.3 of the
15Clinical Psychologist Licensing Act, of a physician assistant
16for a controlled substance in accordance with Section 303.05,
17a written delegation, and a written collaborative agreement
18required under Section 7.5 of the Physician Assistant Practice
19Act of 1987, of an advanced practice registered nurse with
20prescriptive authority delegated under Section 65-40 of the
21Nurse Practice Act who issues a prescription for a controlled
22substance in accordance with Section 303.05, a written
23delegation, and a written collaborative agreement under
24Section 65-35 of the Nurse Practice Act, of an advanced
25practice registered nurse certified as a nurse practitioner,
26nurse midwife, or clinical nurse specialist who has been

 

 

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1granted authority to prescribe by a hospital affiliate in
2accordance with Section 65-45 of the Nurse Practice Act and in
3accordance with Section 303.05 when required by law, or of an
4advanced practice registered nurse certified as a nurse
5practitioner, nurse midwife, or clinical nurse specialist who
6has full practice authority pursuant to Section 65-43 of the
7Nurse Practice Act.
8    (nn-5) "Prescription Information Library" (PIL) means an
9electronic library that contains reported controlled substance
10data.
11    (nn-10) "Prescription Monitoring Program" (PMP) means the
12entity that collects, tracks, and stores reported data on
13controlled substances and select drugs pursuant to Section
14316.
15    (oo) "Production" or "produce" means manufacture,
16planting, cultivating, growing, or harvesting of a controlled
17substance other than methamphetamine.
18    (pp) "Registrant" means every person who is required to
19register under Section 302 of this Act.
20    (qq) "Registry number" means the number assigned to each
21person authorized to handle controlled substances under the
22laws of the United States and of this State.
23    (qq-5) "Secretary" means, as the context requires, either
24the Secretary of the Department or the Secretary of the
25Department of Financial and Professional Regulation, and the
26Secretary's designated agents.

 

 

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1    (rr) "State" includes the State of Illinois and any state,
2district, commonwealth, territory, insular possession thereof,
3and any area subject to the legal authority of the United
4States of America.
5    (rr-5) "Stimulant" means any drug that (i) causes an
6overall excitation of central nervous system functions, (ii)
7causes impaired consciousness and awareness, and (iii) can be
8habit-forming or lead to a substance abuse problem, including
9but not limited to amphetamines and their analogs,
10methylphenidate and its analogs, cocaine, and phencyclidine
11and its analogs.
12    (rr-10) "Synthetic drug" includes, but is not limited to,
13any synthetic cannabinoids or piperazines or any synthetic
14cathinones as provided for in Schedule I.
15    (ss) "Ultimate user" means a person who lawfully possesses
16a controlled substance for his or her own use or for the use of
17a member of his or her household or for administering to an
18animal owned by him or her or by a member of his or her
19household.
20(Source: P.A. 99-78, eff. 7-20-15; 99-173, eff. 7-29-15;
2199-371, eff. 1-1-16; 99-480, eff. 9-9-15; 99-642, eff.
227-28-16; 100-280, eff. 1-1-18; 100-453, eff. 8-25-17; 100-513,
23eff. 1-1-18; 100-789, eff. 1-1-19; 100-863, eff. 8-14-18.)
 
24    Section 115. The Cannabis and Controlled Substances Tort
25Claims Act is amended by changing Section 3 as follows:
 

 

 

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1    (740 ILCS 20/3)  (from Ch. 70, par. 903)
2    Sec. 3. Definitions. As used in this Act, unless the
3context otherwise requires:
4    "Cannabis" includes marihuana, hashish, and other
5substances that are identified as including any parts of the
6plant Cannabis Sativa, whether growing or not, the seeds of
7that plant, the resin extracted from any part of that plant,
8and any compound, manufacture, salt, derivative, mixture, or
9preparation of that plant, its seeds, or resin, including
10tetrahydrocannabinol (THC) and all other cannabinol
11derivatives, including its naturally occurring or
12synthetically produced ingredients, whether produced directly
13or indirectly by extraction, independently by means of
14chemical synthesis, or by a combination of extraction and
15chemical synthesis. "Cannabis" does not include the mature
16stalks of that plant, fiber produced from those stalks, oil or
17cake made from the seeds of that plant, any other compound,
18manufacture, salt, derivative, mixture, or preparation of
19mature stalks (except the extracted resin), fiber, oil or
20cake, or the sterilized seeds of that plant that are incapable
21of germination.
22    "Controlled substance" means a drug, substance, or
23immediate precursor in the Schedules of Article II of the
24Illinois Controlled Substances Act.
25    "Counterfeit substance" means a controlled substance or

 

 

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1the container or labeling of a controlled substance that,
2without authorization, bears the trademark, trade name, or
3other identifying mark, imprint, number, device, or any
4likeness thereof of a manufacturer, distributor, or dispenser
5other than the person who in fact manufactured, distributed,
6or dispensed the substance.
7"Deliver" or "delivery" means the actual, constructive, or
8attempted transfer of possession of a controlled substance or
9cannabis, with or without consideration, whether or not there
10is an agency relationship. "Deliver" or "delivery" does not
11include the donation of drugs to the extent permitted under
12the Illinois Drug Reuse Opportunity Program Act.
13    "Manufacture" means the production, preparation,
14propagation, compounding, conversion, or processing of a
15controlled substance, either directly or indirectly, by
16extraction from substances of natural origin, independently by
17means of chemical synthesis, or by a combination of extraction
18and chemical synthesis, and includes any packaging or
19repackaging of the substance or labeling of its container,
20except that the term does not include:
21        (1) by an ultimate user, the preparation or
22    compounding of a controlled substance for his own use;
23        (2) by a practitioner or his authorized agent under
24    his supervision, the preparation, compounding, packaging,
25    or labeling of a controlled substance:
26            (A) as an incident to his administering or

 

 

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1        dispensing of a controlled substance in the course of
2        his professional practice; or
3            (B) as an incident to lawful research, teaching or
4        chemical analysis and not for sale; or
5        (3) the preparation, compounding, packaging, or
6    labeling of cannabis as an incident to lawful research,
7    teaching, or chemical analysis and not for sale; or .
8        (4) the packaging, repackaging, or labeling of drugs
9    only to the extent permitted under the Illinois Drug Reuse
10    Opportunity Program Act.
11    "Owner" means a person who has possession of or any
12interest whatsoever in the property involved.
13    "Person" means an individual, a corporation, a government,
14a governmental subdivision or agency, a business trust, an
15estate, a trust, a partnership or association, or any other
16entity.
17    "Production" means planting, cultivating, tending, or
18harvesting.
19    "Property" means real property, including things growing
20on, affixed to, and found in land, and tangible or intangible
21personal property, including rights, services, privileges,
22interests, claims, and securities.
23(Source: P.A. 96-328, eff. 8-11-09.)